Nihon Kohden NKV-550 Series Ventilator System

Nihon Kohden NKV-550 Series Ventilator System is an FDA 510(k)-cleared medical device (K192307) manufactured by Nihon Kohden Orangemed, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2020. Regulation: 8.